RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of R115777 in treating patients who have locally advanced or metastatic pancreatic cancer.

Condition	Treatment or Intervention	Phase
childhood gastrointestinal cancer stage II pancreatic cancer stage IVA pancreatic cancer duct cell adenocarcinoma of the pancreas stage III pancreatic cancer stage IVB pancreatic cancer adenocarcinoma of the pancreas	Drug: R115777	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the six month survival rate in patients with advanced adenocarcinoma of the pancreas treated with R115777. II. Determine the time to treatment failure and confirmed response in this patient population treated with this regimen. III. Evaluate the frequency and severity of toxicities associated with this treatment regimen in these patients.

PROTOCOL OUTLINE: Patients receive oral R115777 twice daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 2 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study.

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically or cytologically confirmed adenocarcinoma of the pancreas; Ductal adenocarcinoma; Mucinous noncystic carcinoma Signet ring cell carcinoma; Adenosquamous carcinoma; Undifferentiated (anaplastic) carcinoma; Mixed ductal endocrine carcinoma; Well differentiated adenocarcinoma; Moderately well or poorly differentiated adenocarcinoma; Undifferentiated ductal carcinoma
• No papillary cystic carcinomas, sarcomas, or tumors arising from the endocrine pancreas
• Pathological confirmation of a metastatic site allowed; Clinical documentation of pancreatic involvement and no evidence of another primary allowed
• Locally advanced or distant metastatic disease surgically incurable
• No known brain metastases

--Prior/Concurrent Therapy--

• Biologic therapy: No prior or concurrent immunotherapy
• Chemotherapy: No prior chemotherapy; No prior adjuvant or neoadjuvant chemoradiotherapy, including for advanced pancreatic cancer; No other concurrent chemotherapy
• Endocrine therapy: No prior or concurrent hormonal therapy
• Radiotherapy: See Chemotherapy; No prior radiotherapy, except for palliation to metastatic sites; No concurrent radiotherapy
• Surgery: See Disease Characteristics; At least 2 weeks since prior surgery for pancreatic cancer and recovered; Prior partial resections of the stomach and duodenum for pancreatic cancer allowed; No prior major resection of the small intestine; Prior pancreaticduodenectomy for pancreatic cancer allowed
• Other: No concurrent proton pump inhibitors (e.g., omeprazole); Concurrent antacids or H2 blockers allowed; No other concurrent therapy for pancreatic cancer

--Patient Characteristics--

• Age: Not specified
• Performance status: Zubrod 0-1
• Life expectancy: Not specified
• Hematopoietic: Absolute granulocyte count at least 1,500/mm3; Platelet count at least 100,000/mm3
• Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); SGOT or SGPT no greater than 2.5 times ULN
• Renal: Creatinine no greater than 2.0 mg/dL
• Other: Ability to swallow and/or receive enteral medications via gastrostomy feeding tube; No intractable nausea or vomiting; No other prior malignancy within the past 5 years except adequately treated basal or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer in remission; Not pregnant or nursing; Fertile patients must use effective contraception

California
      University of California Davis Medical Center, Sacramento,  California,  95817,  United States
      USC/Norris Comprehensive Cancer Center, Los Angeles,  California,  90033-0800,  United States
      Veterans Affairs Outpatient Clinic - Martinez, Martinez,  California,  94553,  United States
Illinois
      CCOP - Central Illinois, Decatur,  Illinois,  62526,  United States
Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States
      Veterans Affairs Medical Center - Wichita, Wichita,  Kansas,  67218,  United States
Missouri
      CCOP - Kansas City, Kansas City,  Missouri,  64131,  United States
Montana
      CCOP - Montana Cancer Consortium, Billings,  Montana,  59101,  United States
Ohio
      CCOP - Columbus, Columbus,  Ohio,  43206,  United States
South Carolina
      CCOP - Greenville, Greenville,  South Carolina,  29615,  United States
      CCOP - Upstate Carolina, Spartanburg,  South Carolina,  29303,  United States
Texas
      University of Texas Medical Branch, Galveston,  Texas,  77555-0209,  United States
Washington
      CCOP - Northwest, Tacoma,  Washington,  98405-0986,  United States
      CCOP - Virginia Mason Research Center, Seattle,  Washington,  98101,  United States

Study chairs or principal investigators

John S. Macdonald,  Study Chair,  Southwest Oncology Group   

Study ID Numbers:  CDR0000067846; SWOG-S9924
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  June 2, 2000
ClinicalTrials.gov Identifier:  NCT00005832
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08